›› 2013, Vol. 28 ›› Issue (5): 412-415.DOI: 10.3969/j.issn.1673-8640.2013.05.016

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Performance evaluation of light initiated chemiluminescence system for the determination of thyroid stimulating hormone among pregnant women

  

  1. 1. International Peace Maternity and Child Health Hospital,Shanghai Jiaotong University School of Medicine,Shanghai 200030,China;2.Beyond Diagnostics Inc.,Shanghai 201210,China
  • Received:2012-03-07 Revised:2012-10-17 Online:2013-05-15 Published:2013-05-14

Abstract: Objective To compare the determination results of thyroid stimulating hormone(TSH) by light initiated chemiluminescence(LiCA) system and electro-chemiluminescence(ECL) system among pregnant women,and evaluate the performance of domestic LiCA TSH kit.  Methods Referring to IVD Clinic Research Guideline and the National Academy of Clinical Biochemistry (NACB) guideline,the serum samples of 384 pregnant women were determined by LiCA and ECL systems respectively, and the results were analyzed statistically. Meanwhile, the analytical sensitivity, functional sensitivity, within-run precision, linearity, recovery and interference of LiCA TSH kit were evaluated.  Results There were high correlations in quantitative determination of TSH between the 2 systems with no statistical significance(P>0.05). The analytical sensitivity and functional sensitivity of LiCA TSH kit were 0.001 1 and 0.017 μIU/mL. The within-run precisions of high-level and low-level quality controls (QCH and QCL) were 1.42% and 1.55%, and the recoveries were 97.01% and 101.57%. The linearity analysis showed Y=24.58X-22.9(r=0.998, P<0.05). 250 mg/dL hemoglobin, 500 mg/dL triglyceride and 10 mg/dL bilirubin had no interference to the determination results.  Conclusions There is no significant difference between LiCA system and import ECL system for the quantitative determination of TSH among pregnant women. LiCA is suitable to the clinical application.

Key words: Thyroid stimulating hormone, Light initiated chemiluminescence, Performance evaluation, Pregnant woman